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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J. 21 U.S.C. §

Clinic 59
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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law

There is much to unpack, and we intend to do so in a series of blog posts. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” . In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Law

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). academic medical center laboratories). We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy.

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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! This situation is also vastly different from “help seeking” communications that center mostly around treatment without mentioning the treatment name.

IT 40
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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law

FDA’s Center for Drug Evaluation and Research Controlled Substances Staff conducts the scheduling analysis and makes recommendations. whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 802(16)(A).

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